EARly Prevention of aTHeroma Progression

Coronary Arteriosclerosis Clinical Trial

— EARTH  

Official title:

EARly Prevention of aTHeroma Progression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02105623
• Other study ID #: AMCCV2013-09
• Status: Terminated
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: March 2018

Study information

• Verified date: June 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare standard therapy (risk factor control, life style modification) versus standard therapy plus low-dose rosuvastatin therapy (5mg/day) on progression of coronary atherosclerosis in statin naive individuals who have mild CAD (nonobstructive coronary atherosclerotic plaques) and normal LDL (low-density lipoprotein) cholesterol levels(〈130mg/dl).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Men or women at least 35 years of age

• Mild CAD (nonobstructive coronary atherosclerotic plaques, lumen narrowing <50%) and CAC score <300 in at least one segment of proximal or mid-portion of major epicardial coronary arteries

• LDL cholesterol <130mg/dl

Exclusion Criteria:

• History of stable angina, or acute coronary syndrome

• History of transient ischemic attack, or stroke

• Chronic kidney disease (eGFR< 60ml/min)

• Diabetes mellitus with microvascular complications or insulin therapy

• Hypertriglyceridemia (triglyceride >500mg/dl)

• Any statin therapy in the past 4 weeks

• Planned cardiac surgery or planned major non-cardiac surgery within 6 months.

• Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).

• A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.

• Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.

• Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).

• History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).

• Unwillingness or inability to comply with the procedures described in this protocol.

• Positive pregnancy test (all female subjects of childbearing potential must have a urine ß-human chorionic gonadotropin(hCG) pregnancy test performed at Screening and/ or within 7 days prior to randomization) or is known to be pregnant or lactating.

• Hypersensitivity to Crestor

• Skeletal muscle disease

• Combination use with cyclosporine

• Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption

• Combination use of protease inhibitor

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia
• Plaque, Atherosclerotic

Intervention

Behavioral:
• Standard Therapy
Risk factor control Diet Exercise for 24months

Drug:
• Rosuvastatin
Risk factor control rosuvastatin 5mg/day for 24months

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
CHEOL WHAN LEE, M.D., Ph.D	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in total atheroma volume(TAV)	Percent change in total atheroma volume(TAV) at region of interest defined as(TAV at 24 months-TAV at baseline)/(TAV at baseline)x 100	2 years
Secondary	Change in PAV(Percent atheroma volume) at region of interest	Change in PAV(Percent atheroma volume) at region of interest(PAV at 24months-PAV at baseline)	2years
Secondary	Change in overall TAV	Sum of TAV in all coronary segments	2years
Secondary	Change in TAV at region of interest	TAV at 24months-TAV at baseline	2years
Secondary	Change in overall CAC(coronary artery calcification) score	overall CAC score at 24months-overall CAC score at baseline	2years
Secondary	Change in number of segment of any coronary atherosclerotic plaques		2years
Secondary	Percent change from baseline in lipid levels		2years